Principal Quality Engineer - AI/​ML Digital Health

About the Role

We are seeking a Principal Quality Engineer (AI/ML Digital Health) to join our team at RecovryAI. This fully remote position offers flexible working hours and the opportunity to make a significant impact in the field of medical AI. As a Principal Quality Engineer, you will play a crucial role in shaping and executing quality strategies across our software-driven, AI-enabled digital health platform.

What You'll Do

• Serve as the primary Quality representative across product development, software engineering, clinical, and sustaining activities, ensuring quality and compliance are embedded throughout the full product lifecycle.
• Partner closely with Regulatory, Engineering, Product, Clinical, Security, and Operations teams to ensure alignment with FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, IEC62304, software lifecycle expectations, and internal quality system requirements.
• Own and lead product risk management activities, including the development, maintenance, and continuous updating of the Risk Management File, with integrated consideration of software, AI/ML, cybersecurity, data, and clinical workflow risks.
• Define, oversee, and approve software verification and validation (V&V) strategies, including automated and manual testing approaches, ensuring robust traceability from user needs and system requirements through test execution and results.
• Lead the definition, review, and lifecycle management of requirements (e.g., user needs, system requirements, software requirements), ensuring they are clear, testable, risk-informed, and suitable for agile development environments.
• Assist with driving Quality Management System (QMS) development and implementation, to align quality practices with the needs of a growing digital health organization.
• Manage activities related to the electronic Quality Management System (eQMS), including document control, change management, training, and system configuration to ensure sustained effectiveness and audit readiness.
• Lead post-market surveillance activities, including complaint handling, issue trending, investigation oversight, and communication of product quality and performance metrics to leadership and cross-functional stakeholders.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or a related technical discipline (Master’s preferred).
• 8+ years in the medical device industry with demonstrated experience supporting software-driven or AI-enabled products, with emphasis on Design Assurance, Software Quality, and Product Development support.
• Direct experience with SaMD products strongly preferred.
• Knowledge of FDA regulations, ISO 13485, ISO 14971, IEC 62304 and applicable FDA SAMD guidance documents.
• Proficient in risk management tools (FMEA, FTA) and design V&V processes.
• Hands-on experience leading software requirements management, software risk analysis, and software testing activities, including formal V&V.
• Hands-on experience with eQMS platforms and document control management.
• Experience leading complaint handling, post-market surveillance, and trending activities.

Nice to Have

• ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) preferred.

What We Offer

• Fully remote position with flexible working hours.
• Opportunity to make a significant impact in medical AI.
• Direct collaboration with deeply experienced technical leadership.
• Growth opportunities as we scale our team and product.
• Competitive compensation, including employee stock options and health benefits.

At RecovryAI, you will join a collaborative, mission-driven team focused on transforming post-operative recovery through AI-enabled digital health solutions and clinically informed virtual care. In this role, you will play a visible and influential role in advancing product development, quality compliance, and commercial readiness—helping build the quality foundation that supports innovation and long-term growth.